Fluanxol

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Fluanxol®

(flu-ANK-sol)

Fluanxol® Depot 20 mg/mL

Fluanxol® Concentrated Depot 100 mg/mL

Flupenthixol decanoate (flu-PEN-thic-sol deck-can-OH-ate)

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet contains answers to some common questions about Fluanxol.

It does not contain all the information that is known about Fluanxol. It does not take the place of talking to your doctor
or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she
expects it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Fluanxol is used for

Fluanxol is used for the long-term treatment of schizophrenia, a mental illness with disturbances in thinking, emotional reactions
and behaviour, and other chronic mental conditions.

Fluanxol belongs to a group of medicines called thioxanthene neuroleptics. It helps to correct chemical imbalances in the
brain, which may cause mental illness.

Your doctor, however, may prescribe it for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

This medicine is only available with a doctor's prescription.

Fluanxol is not addictive.

Before you are given it

When you must not be given it

Do not use Fluanxol if you are allergic to it, to any other similar medicines (such as thioxanthenes or phenothiazines), or
the ingredient fractionated coconut oil.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face,
lips, tongue or other parts of the body, or rash, itching or hives on the skin.

Do not use Fluanxol if you have:

diminished consciousness due to any cause

collapse due to very low blood pressure

brain damage

diseases of the blood with a reduced number of red or white blood cells or platelets

phaeochromocytoma, a rare tumour of the adrenal gland which sits near the kidney.

Do not give Fluanxol to anyone who currently has alcohol poisoning, or poisoning with medicines used to produce calmness or
to help you sleep, or medicines used to treat epilepsy or strong pain.

Do not give Fluanxol to anyone who is unconscious or in a coma.

Do not give Fluanxol to a child or adolescent.

There is no experience with its use in children or adolescents under 18 years old.

Do not give Fluanxol to patients with mental illness who are highly distressed, or elderly patients who are confused and/or
distressed.

Do not use it after the expiry date printed on the pack.

If you use it after the expiry date has passed, it may not work as well. The expiry date refers to the last day of the month.

Do not use it if the packaging is torn or shows signs of tampering.

Before you are given it

Tell your doctor if:

1.you have allergies to any other substances such as foods, preservatives or dyes.

2.you are pregnant or intend to become pregnant.

Fluanxol may affect your fertility. If you are intending to start a family, ask your doctor for advice.

Like most medicines of this kind, Fluanxol is not recommended for use during pregnancy unless clearly necessary. The general
condition of your baby might be affected by the use of this medicine.

The following symptoms may occur in newborn babies of mothers who have used Fluanxol in the last three months of their pregnancy:
shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding. If your baby
develops any of these symptoms you should contact your doctor.

3.you are breast-feeding or planning to breast-feed.

It is not recommended that you breast-feed while using Fluanxol. Its active ingredient passes into breast milk and therefore
there is a possibility that your baby might be affected.

4.you have, or have had, the following medical conditions:

arteriosclerosis, a disease affecting the arteries

convulsions, fits or seizures

decreased blood supply to the brain

diabetes, a disorder of metabolism in which the amount of sugar in the blood is too high

glaucoma, a condition in which there is usually a build-up of pressure in the eye

heart and blood vessel problems

kidney problems

liver problems

low potassium and/or low magnesium levels in the blood

organic brain syndrome

parkinsonism, a disease of the brain affecting movement

risk factors for stroke

tardive dyskinesia, a reaction to some medicines with worm-like movements of the tongue, or other uncontrolled movements of
the mouth, tongue, cheeks or jaw which may progress to the arms and legs.

Treatment for cancer

If you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation
of blood clots

Also tell your doctor if you will be in a hot environment or you do a lot of vigorous exercise.

Fluanxol may make you sweat less, causing your body to overheat.

Tell your doctor if you are exposed to pesticides that contain phosphorus.

The risk of you experiencing a side effect may be increased.

If you have not told your doctor about any of the above, tell them before you are given Fluanxol.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy,
supermarket or health food shop.

Some medicines and Fluanxol may interfere with each other. These include:

phenobarbitone and carbamazepine, medicines used to treat convulsions and epilepsy

medicines used to treat strong pain

medicines used to produce calmness or to help you sleep

medicines used to treat high blood pressure (hypertension), including debrisoquine, guanethidine and clonidine

levodopa, a medicine used to treat Parkinson's disease

medicines which stimulate the body, getting it ready for action, such as adrenaline

metoclopramide, a medicine used to relieve nausea and vomiting

piperazine, a medicine used to treat worm infections

medicines used to treat changes in the rhythm or rate of the heart beat, e.g. quinidine, amiodarone, sotalol and dofetilide

antipsychotics, a class of medicines used to treat certain mental and emotional conditions, e.g. thioridazine

certain medicines used to treat infections, such as erythromycin, gatifloxacin and moxifloxacin

medicines used to relieve the symptoms of allergy, including terfenadine and astemizole

cisapride, used to treat stomach problems

medicines that disturb water or salt balance e.g. thiazide diuretics, also called fluid or water tablets

medicines known to increase the concentration of Fluanxol in your blood

medicines used to relieve stomach cramps or spasms, to prevent travel sickness and to treat Parkinson's disease, such as atropine
or related medicines.

medicines used to treat cancer

These medicines may be affected by Fluanxol, or may affect how well it works. You may need to use different amounts of your
medicines, or take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while using Fluanxol.

How it is given

How much is given

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight
and your response to the medicine.

Fluanxol Depot

Generally, the starting dose is 20 to 40 mg (1 to 2 mL). A second dose of 20 to 40 mg (1 to 2 mL) is usually given 4-10 days
after the first injection, and further doses are given every 2 to 4 weeks for the majority of patients.

Fluanxol Concentrated Depot

Patients who require higher doses and/or who have problems with larger injection volumes may be given Fluanxol Concentrated
Depot.

Your doctor may have prescribed a different dose.

Ask your doctor or pharmacist if you are unsure of the correct dose for you. Follow the instructions they give you.

They will tell you exactly how much you will be given.

How it is given

Fluanxol is given as an injection into a large muscle where it is slowly released over time. The injection should only be
given by a doctor, nurse or other trained person.

How often it is given

It is recommended that Fluanxol is given every 2-4 weeks, depending on how your body responds to the medicine.

How many injections you will need

Continue having your injections for as long as your doctor tells you to.

Fluanxol helps control your condition, but does not cure it. Therefore, you will need regular injections.

If you forget to have an injection

If you forget to keep an appointment, contact your doctor as soon as you remember, so that you can make another one.

Overdose

As Fluanxol is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

However, if you experience any side effects after being given Fluanxol, immediately telephone your doctor, or the Poisons
Information Centre (Tel: 13 11 26 for Australia and Tel: 0800 764 766 for New Zealand), or go to Accident and Emergency at
your nearest hospital.

You may need urgent medical attention.

Symptoms of an overdose may include sleepiness, coma, extreme agitation, excitement, confusion, convulsions and extremely
high or low body temperature. Uncontrollable movements may develop, and collapse due to very low blood pressure or difficulty
breathing may occur. Changes in the rhythm or rate of the heart beat have been seen in Fluanxol overdose when medicines known
to affect the heart have also been taken.

While you are using it

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Fluanxol.

Tell any other doctors, dentists and pharmacists who treat you that you are using this medicine.

If you become pregnant while using Fluanxol, tell your doctor immediately.

Tell your doctor immediately if you notice any worm-like movements of the tongue, or other uncontrolled movements of the tongue,
mouth, cheeks or jaw which may progress to the arms and legs.

These are symptoms of a condition called tardive dyskinesia, which may develop in people taking similar medicines, including
Fluanxol.

This condition is more likely to occur during long-term treatment with Fluanxol, especially in elderly women. In very rare
cases, this may be permanent. However, if detected early, these symptoms are usually reversible.

Also tell your doctor if you notice any soreness of the mouth, gums, throat or other flu-like symptoms.

Talk to your doctor or mental health professional if you are thinking or talking about death, suicide, self-harm or harm to
others.

These may be signs of changes or worsening in your mental illness.

If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine.

Fluanxol may affect other medicines used during surgery.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked.

Your doctor may do some blood and liver tests from time to time, particularly during the first months of therapy, to make
sure the medicine is working and to prevent unwanted side effects.

Protect your skin when you are in the sun, especially between 10am and 3pm.

If you are outdoors, wear protective clothing and use a 30+ sunscreen.

If your skin appears to be burning, tell your doctor.

Fluanxol may cause your skin to be much more sensitive to sunlight than it is normally. This could cause skin rash, itching,
redness, or severe sunburn.

Things you must not do

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not take any medicines that cause drowsiness while you are using Fluanxol, unless recommended by your doctor.

Do not miss any injections, even if you feel better.

Fluanxol helps control your condition, but does not cure it. Therefore, you will need regular injections.

Do not stop using Fluanxol suddenly.

If Fluanxol is stopped suddenly, you may experience symptoms such as nausea, vomiting, loss of appetite, diarrhoea, runny
nose, sweating, aching muscles, pins and needles, sleeplessness, restlessness, anxiety, or agitation.

Your doctor may want to gradually reduce the amount you are given before stopping completely.

Things to be careful of

Be careful driving or operating machinery until you know how Fluanxol affects you.

It may cause drowsiness, tiredness, sleepiness or blurred vision in some people. If you have any of these symptoms, do not
drive, operate machinery, or do anything else that could be dangerous.

Be careful when drinking alcohol while you are using this medicine.

If you drink alcohol, drowsiness or sleepiness may be worse.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

Standing up slowly will help your body get used to the change in position and blood pressure. If this problem continues or
gets worse, talk to your doctor.

Side effects

All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor
has weighed the risks of using this medicine against the benefits he/she expects it will have for you.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Fluanxol.

It helps most people with mental illness, but it may have unwanted side effects in a few people.

If you are over 65 years of age you may have an increased chance of getting side effects.

Tell your doctor if you notice any of the following and they worry you:

restlessness

nervousness, agitation

difficulty sleeping

involuntary muscle contractions

slowing of movements

painful or weak muscles

headache, dizziness

drowsiness or somnolence

tiredness, fatigue

dry mouth

constipation or diarrhoea

increased salivation or increased sweating

nausea, vomiting, dyspepsia

weight and appetite changes

depression

impaired sexual function

change in your menstrual periods

skin rash, itchy skin

hair loss

pain at the place where your injection is given.

Tell your doctor immediately if you notice any of the following:

sudden onset of unusual movements, including trembling and shaking of the hands and fingers, twisting movements of the body,
or shuffling walk and stiffness of the arms and legs

worm-like movements of the tongue or other uncontrolled movements of the mouth, tongue, cheeks or jaws, which may progress
to the arms and legs

Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel
through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek
medical advice immediately.

In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics
compared with those not receiving antipsychotics.

These may be serious side effects of Fluanxol. You may need urgent medical attention.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice any of the following:

serious allergic reaction (symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat which
may cause difficulty in swallowing or breathing, or hives)

convulsions

sudden increase in body temperature, unusual stiffness of the muscles and changes in consciousness, especially in conjunction
with fast heart rate and sweating. This may be due to a very rare condition called neuroleptic malignant syndrome, which
has been reported with various antipsychotic medicines.

These are very serious side effects. You may need urgent medical attention or hospitalisation.

These side effects are generally rare.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may occur in some people.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After using it

Storage

Keep Fluanxol in the pack until it is time to use it.

If you take the ampoules out of the box they may not keep well.

Keep Fluanxol away from sunlight.

Keep the medicine in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.

Do not leave it in the car.

Heat and damp can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor stops giving you this medicine, or the expiry date has passed, ask your pharmacist what to do with any that
is left over.

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